Debendox in early pregnancy and fetal malformation.
During the mid-1960s, 22 977 pregnant women in Scotland and England were followed up prospectively for the incidence of malformations in their infants evident at birth or within six weeks. During the first 13 weeks of gestation 620 of these women had been prescribed Debendox (dicyclomine-doxylamine-pyridoxine) and 743 other women agents other than Debendox containing pyridoxine. Of the 620 women given Debendox, 589 (95%) had a normal outcome of pregnancy, 8 (13%) delivered a malformed infant, and 23 (3.7%) had other outcomes. Of the 22 357 women who were given Debendox, 445 (2.0%) produced infants with malformation; and the rates for all abnormal outcomes among women given Debendox and those not given the drug were 5.0% and 5.4% respectively. These results support the hypothesis that Debendox is not teratogenic.
D000014:Abnormalities, Drug-Induced / Q000453:epidemiology / Q000209:etiology*; D003509:Cyclohexanecarboxylic Acids / Q000009:adverse effects*; D004025:Dicyclomine / Q000009:adverse effects*; D004319:Doxylamine / Q000009:adverse effects*; D004338:Drug Combinations; D004739:England; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D011247:Pregnancy; D011261:Pregnancy Trimester, First; D011446:Prospective Studies; D011725:Pyridines / Q000009:adverse effects*; D011736:Pyridoxine / Q000009:adverse effects*; D012606:Scotland
D003509:Cyclohexanecarboxylic Acids; D004338:Drug Combinations; D011725:Pyridines; D004025:Dicyclomine; D004319:Doxylamine; D011736:Pyridoxine